Trial Outcomes & Findings for A Phase I Trial of Vandetanib (AZD6474) and Selumetinib (AZD6244) for Solid Tumours Including Non Small Cell Lung Cancer (VanSel-1) (NCT NCT01586624)
NCT ID: NCT01586624
Last Updated: 2021-10-07
Results Overview
Number of serious adverse events, non-serious adverse events and treatment emergent adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months).
Results posted on
2021-10-07
Participant Flow
Trial participants were enrolled at three trial sites between 10 January 2012 and 19 September 2017.
Participant milestones
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
9
|
8
|
8
|
11
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
5
|
7
|
8
|
8
|
8
|
10
|
Reasons for withdrawal
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
1
|
3
|
3
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Evidence of disease progression
|
1
|
3
|
2
|
5
|
3
|
5
|
4
|
6
|
|
Overall Study
Screen failure (no treatment received)
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib )
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib )
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=9 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=11 Participants
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=11 Participants
|
29 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=11 Participants
|
32 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=11 Participants
|
31 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=11 Participants
|
30 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
7 participants
n=7 Participants
|
9 participants
n=9 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
11 participants
n=11 Participants
|
61 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months).Population: All patients who met the eligibility criteria and received at least one dose of the combination treatment (vandetanib and selumetinib) were evaluable for safety assessment (N=57).
Number of serious adverse events, non-serious adverse events and treatment emergent adverse events.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=11 Participants
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events.
Total SAEs
|
10 Adverse events
|
11 Adverse events
|
13 Adverse events
|
5 Adverse events
|
28 Adverse events
|
10 Adverse events
|
14 Adverse events
|
14 Adverse events
|
|
Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events.
Total NSAEs
|
99 Adverse events
|
90 Adverse events
|
70 Adverse events
|
94 Adverse events
|
161 Adverse events
|
98 Adverse events
|
114 Adverse events
|
130 Adverse events
|
|
Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events.
Total treatment emergent AEs
|
107 Adverse events
|
99 Adverse events
|
79 Adverse events
|
93 Adverse events
|
165 Adverse events
|
102 Adverse events
|
126 Adverse events
|
135 Adverse events
|
PRIMARY outcome
Timeframe: DLTs occurring in the first Cycle (up to Day 42).Population: All patients who met the eligibility criteria and received at least one dose of the combination treatment (vandetanib and selumetinib) were evaluable for safety assessment (N=57).
Number of DLTs within each cohort.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=11 Participants
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities (DLTs) Within Each Cohort.
|
1 DLTs
|
0 DLTs
|
1 DLTs
|
1 DLTs
|
2 DLTs
|
1 DLTs
|
1 DLTs
|
2 DLTs
|
SECONDARY outcome
Timeframe: 0 hours (pre dose) and at 0.5, 2, 4, 6 and 24 hours post dose on Day 4. 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29.Population: All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data).
Maximum observed plasma concentration of vandetanib post treatment with vandetanib alone and following the combination of vandetanib and selumetinib.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Vandetanib.
Day 4
|
585 ng/mL
Interval 428.0 to 947.0
|
561 ng/mL
Interval 223.0 to 1500.0
|
582 ng/mL
Interval 422.0 to 890.0
|
790 ng/mL
Interval 337.0 to 1210.0
|
484.5 ng/mL
Interval 379.0 to 733.0
|
702.5 ng/mL
Interval 382.0 to 910.0
|
702 ng/mL
Interval 526.0 to 1390.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Vandetanib.
Day 15
|
503.5 ng/mL
Interval 319.0 to 765.0
|
436 ng/mL
Interval 206.0 to 703.0
|
414.5 ng/mL
Interval 367.0 to 605.0
|
476 ng/mL
Interval 301.0 to 796.0
|
401.5 ng/mL
Interval 273.0 to 592.0
|
701 ng/mL
Interval 446.0 to 1260.0
|
906 ng/mL
Interval 713.0 to 1380.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Vandetanib.
Day 29
|
556 ng/mL
Interval 384.0 to 690.0
|
399 ng/mL
Interval 284.0 to 605.0
|
538 ng/mL
Interval 288.0 to 704.0
|
503 ng/mL
Interval 306.0 to 695.0
|
335.5 ng/mL
Interval 183.0 to 346.0
|
988 ng/mL
Interval 522.0 to 1240.0
|
902 ng/mL
Interval 481.0 to 1160.0
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29.Population: All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data).
Maximum observed plasma concentration of selumetinib post treatment with the combination of vandetanib and selumetinib.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Selumetinib.
Day 29
|
430 ng/mL
Interval 193.0 to 852.0
|
569 ng/mL
Interval 363.0 to 1030.0
|
1220 ng/mL
Interval 553.0 to 1920.0
|
1740 ng/mL
Interval 1370.0 to 2550.0
|
1440 ng/mL
Interval 1430.0 to 2190.0
|
587 ng/mL
Interval 564.0 to 1200.0
|
593 ng/mL
Interval 262.0 to 1100.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Selumetinib.
Day 15
|
324.5 ng/mL
Interval 134.0 to 698.0
|
605 ng/mL
Interval 415.0 to 828.0
|
1280 ng/mL
Interval 529.0 to 1870.0
|
1890 ng/mL
Interval 320.0 to 3060.0
|
2005 ng/mL
Interval 853.0 to 2810.0
|
501 ng/mL
Interval 326.0 to 782.0
|
814 ng/mL
Interval 489.0 to 981.0
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre dose) and at 0.5, 2, 4, 6 and 24 hours post dose on Day 4. 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29.Population: All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data).
Area under the plasma concentration time curve (0-24 hours) of vandetanib post treatment with vandetanib alone and following the combination of vandetanib and selumetinib.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-24 Hours) of Vandetanib.
Day 4
|
12032 h*ng/mL
Interval 9115.0 to 19402.0
|
11629.5 h*ng/mL
Interval 4861.0 to 30192.0
|
11189 h*ng/mL
Interval 8989.0 to 17979.0
|
16603 h*ng/mL
Interval 7448.0 to 21877.0
|
10286.5 h*ng/mL
Interval 8056.0 to 14169.0
|
14395 h*ng/mL
Interval 8082.0 to 20965.0
|
14830.5 h*ng/mL
Interval 11310.0 to 26269.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-24 Hours) of Vandetanib.
Day 15
|
9253.5 h*ng/mL
Interval 6583.0 to 15931.0
|
8822.5 h*ng/mL
Interval 4659.0 to 15225.0
|
7958.5 h*ng/mL
Interval 7047.0 to 13606.0
|
9946 h*ng/mL
Interval 6142.0 to 17340.0
|
8814.5 h*ng/mL
Interval 6045.0 to 13325.0
|
15442 h*ng/mL
Interval 8212.0 to 27375.0
|
18864 h*ng/mL
Interval 14032.0 to 29896.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-24 Hours) of Vandetanib.
Day 29
|
12555 h*ng/mL
Interval 8673.0 to 15077.0
|
8355 h*ng/mL
Interval 5977.0 to 13598.0
|
11246 h*ng/mL
Interval 6434.0 to 15271.0
|
10058 h*ng/mL
Interval 6871.0 to 15763.0
|
7261.5 h*ng/mL
Interval 3801.0 to 7482.0
|
18573 h*ng/mL
Interval 11362.0 to 25692.0
|
15923 h*ng/mL
Interval 9987.0 to 24112.0
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre dose) and at 0.5, 2, 4, 6 and 10 hours post dose on Days 15 and 29.Population: All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data).
Area under the plasma concentration time curve (0-12 hours) of selumetinib post treatment with the combination of vandetanib and selumetinib. This was extrapolated from the sampling data up to 10 hours to allow comparison with literature data.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of Selumetinib.
Day 15
|
1251.5 h*ng/mL
Interval 639.0 to 2361.0
|
2050 h*ng/mL
Interval 1542.0 to 3607.0
|
4072.5 h*ng/mL
Interval 2111.0 to 5615.0
|
6138 h*ng/mL
Interval 2045.0 to 10777.0
|
6921 h*ng/mL
Interval 4600.0 to 9329.0
|
1698 h*ng/mL
Interval 1391.0 to 3028.0
|
2770 h*ng/mL
Interval 2015.0 to 3550.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of Selumetinib.
Day 29
|
1913 h*ng/mL
Interval 1400.0 to 2122.0
|
2550 h*ng/mL
Interval 1386.0 to 4494.0
|
4762 h*ng/mL
Interval 2685.0 to 9798.0
|
6998 h*ng/mL
Interval 4165.0 to 11326.0
|
6429 h*ng/mL
Interval 6306.0 to 7768.0
|
3049 h*ng/mL
Interval 2843.0 to 3753.0
|
2477 h*ng/mL
Interval 1094.0 to 3277.0
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre dose) and at 0.5, 2, 4, 6 and 10 hours post dose on Days 15 and 29.Population: All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data).
Area under the plasma concentration time curve (0-12 hours) of N-desmethyl metabolite of selumetinib following the combination of vandetanib and selumetinib. This was extrapolated from the sampling data up to 10 hours to allow comparison with literature data.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=8 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of N-desmethyl Metabolite of Selumetinib.
Day 15
|
78.5 h*ng/mL
Interval 44.0 to 149.0
|
141 h*ng/mL
Interval 127.0 to 332.0
|
255 h*ng/mL
Interval 88.0 to 407.0
|
349 h*ng/mL
Interval 145.0 to 925.0
|
493 h*ng/mL
Interval 328.0 to 686.0
|
182 h*ng/mL
Interval 95.0 to 338.0
|
236 h*ng/mL
Interval 144.0 to 340.0
|
—
|
|
Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of N-desmethyl Metabolite of Selumetinib.
Day 29
|
89 h*ng/mL
Interval 59.0 to 251.0
|
163 h*ng/mL
Interval 126.0 to 288.0
|
230 h*ng/mL
Interval 125.0 to 535.0
|
390 h*ng/mL
Interval 189.0 to 758.0
|
377 h*ng/mL
Interval 348.0 to 383.0
|
293 h*ng/mL
Interval 173.0 to 475.0
|
205 h*ng/mL
Interval 83.0 to 256.0
|
—
|
SECONDARY outcome
Timeframe: 10 and 18 weeks from date of first dose of vandetanib.Population: All patients in the expansion cohort receiving at least one cycle\* of the vandetanib and selumetinib combination with a baseline assessment of disease (N=9). \*To be evaluable for response, a patient must have received a minimum of 21 of the 28 daily doses of the combination treatment in Cycle 1.
PFS by Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0). Per RECIST for target lesions and assessed by computerised tomography (CT), progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum while on trial, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=9 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Cohort Only: Progression Free Survival (PFS) of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib.
Progression free at 10 weeks
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Progression Free Survival (PFS) of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib.
Progression free at 18 weeks
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year from date of first dose of vandetanib.Population: All patients in the expansion cohort receiving at least one cycle\* of the vandetanib and selumetinib combination with a baseline assessment of disease (N=9). \*To be evaluable for response, a patient must have received a minimum of 21 of the 28 daily doses of the combination treatment in Cycle 1.
Number of patients alive at one year.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=9 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Cohort Only: One Year Survival of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib.
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 12, Day 42.Population: All patients in the expansion cohort receiving at least one cycle\* of the vandetanib and selumetinib combination with a baseline assessment of disease (N=9). \*To be evaluable for response, a patient must have received a minimum of 21 of the 28 daily doses of the combination treatment in Cycle 1.
Tumour metabolism using 18F-fluorodeoxyglucose positron emission tomography (\[18F\]FDG-PET) computerised tomography (CT) imaging pre and post treatment with vandetanib alone and following the combination of vandetanib and selumetinib. These were assessed and reported according to PERCIST criteria.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=9 Participants
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 12 Complete Metabolic Response
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 12 Partial Metabolic Response
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 12 Stable Metabolic Disease
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 12 Progressive Metabolic Disease
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 42 Complete Metabolic Response
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 42 Partial Metabolic Response
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 42 Stable Metabolic Disease
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 42 Progressive Metabolic Disease
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria.
Day 42 Not assessed
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
Serious events: 7 serious events
Other events: 8 other events
Deaths: 1 deaths
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
Serious events: 8 serious events
Other events: 11 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=7 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=11 participants at risk
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Retinopathy
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
25.0%
2/8 • Number of events 8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
12.5%
1/8 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Disease Progression
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Fever
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Stroke
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
Other adverse events
| Measure |
Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib)
n=7 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib)
n=8 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=7 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib)
n=6 participants at risk
Dose escalation to determine the recommended dose and schedule for Phase 2 evaluation of vandetanib and selumetinib.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib)
n=11 participants at risk
Expansion cohort at the recommended phase 2 dose of vandetanib and selumetinib defined in the escalation phase.
Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Chest pain - cardiac
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Blurred vision
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Flashing lights
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Floaters
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Eye disorders
Glaucoma
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
37.5%
3/8 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
5/6 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
83.3%
5/6 • Number of events 12 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
83.3%
5/6 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
57.1%
4/7 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
62.5%
5/8 • Number of events 17 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
100.0%
7/7 • Number of events 17 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
83.3%
5/6 • Number of events 14 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
72.7%
8/11 • Number of events 16 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
71.4%
5/7 • Number of events 9 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
4/8 • Number of events 8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
57.1%
4/7 • Number of events 8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
36.4%
4/11 • Number of events 8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
71.4%
5/7 • Number of events 10 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
12.5%
1/8 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
57.1%
4/7 • Number of events 10 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Chills
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Disease Progression
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
83.3%
5/6 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
83.3%
5/6 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
54.5%
6/11 • Number of events 10 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Fever
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Flu like symptoms
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
General disorders
Pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Infections and infestations
Vaginal infection
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
66.7%
4/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
66.7%
4/6 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Cholesterol high
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
CPK increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
66.7%
4/6 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
4/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
25.0%
2/8 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
4/8 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
25.0%
2/8 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Cystitis noninfective
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
28.6%
2/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
83.3%
5/6 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
57.1%
4/7 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
62.5%
5/8 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
63.6%
7/11 • Number of events 8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
33.3%
2/6 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
16.7%
1/6 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
14.3%
1/7 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
42.9%
3/7 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
50.0%
3/6 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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 final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/7 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/6 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). Overall Mortality was collected during the Safety data assessment period for the dose Escalation Cohorts and up to one year after Cycle 1 Day 1 for the Expansion Cohort.
Per protocol, where deaths due to disease progression were reported as AEs, these weren't considered to be SAEs unless related to the IMP. These events were coded by the Sponsor as "Death NOS" in the clinical database but have been entered as disease progression at the request of ClinicalTrials.gov. For patients recruited to the expansion cohort, deaths due to disease progression in the survival follow-up period were not reported as AEs but have been included in the All-cause mortality numbers.
|
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