Trial Outcomes & Findings for Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies (NCT NCT03363893)
NCT ID: NCT03363893
Last Updated: 2026-06-23
Results Overview
Treatment-emergent adverse events (TEAEs) are defined as those AEs which occur from Cycle 0 Day 1/Cycle 1 Day 1 of the study module to 28 days after the last dose of CT7001 in a module. Results reported below for Participants with one or more related TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Screening to end of study (28-35 calendar days after end of treatment). End of treatment at disease progression, unacceptable toxicity or withdrawal of consent. Average time on study 142.6 days (range 9 - 1135 days)
Results posted on
2026-06-23
Participant Flow
This study recruited participants at least 18 years of age with histological or cytological confirmation of an advanced malignancy, with an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy greater than 12 weeks.
A total of 174 participants were recruited, of which 124 participants were enrolled and went on to receive study treatment with CT7001. Of the 174 participants screened, 50 participants did not receive study treatment, of which 46 participants did not meet the study enrolment criteria and 4 participants withdrew from the study.
Participant milestones
| Measure |
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose
|
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 5 180 mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2 Part A CT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2 Part A CT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4-120 mg OD Fed-Fasted (Sequence 1)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 1: 120 mg CT7001 fed in Period 1 followed by 120 mg CT7001 fasted in Period 2.
|
Module 4 120 mg OD Fasted-Fed (Sequence 2)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 2: 120 mg CT7001 fasted in Period 1 followed by 120 mg CT7001 fed in Period 2.
|
Module 4 360 mg OD Fed-Fasted (Sequence 3)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360 mg CT7001 fasted in Period 2.
|
Module 4 360 mg OD Fasted-Fast (Sequence 4)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period 1 followed by 360 mg CT7001 fed in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
8
|
5
|
6
|
23
|
11
|
6
|
25
|
4
|
4
|
4
|
3
|
|
Overall Study
COMPLETED
|
6
|
7
|
6
|
6
|
8
|
5
|
6
|
23
|
11
|
6
|
25
|
4
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Module 1 Part A-Cohort 1 120mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240 mg OD
n=7 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day
1. of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose
|
Module 1 Part A-Cohort 3 480 mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day
1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360 mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day
1. of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 5 180 mg BID
n=8 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day
1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D)
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=6 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=23 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2 Part A CT7001 240 mg OD + Fulvestrant (Cohort 1)
n=6 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2 Part A CT7001 360 mg OD + Fulvestrant (Cohort 2)
n=25 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection. CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression. Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4-120 mg OD Fed-Fasted (Sequence 1)
n=4 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:
120 mg CT7001 fed in Period 1 followed by 120 mg CT7001 fasted in Period 2. This was followed by ) followed by 240mg OD continuous dosing.
|
Module 4 120 mg OD Fasted-Fed (Sequence 2)
n=4 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 2:
120 mg CT7001 fasted in Period
1 followed by 120 mg CT7001 fed in Period 2. ). This followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed-Fasted (Sequence 3)
n=4 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3:
360 mg CT7001 fed in Period 1 followed by 360 mg CT7001 fasted in Period 2. ). This was followed by 360mg OD continuous dosing
|
Module 4 360 mg OD Fasted-Fed (Sequence 4)
n=3 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4:
360 mg CT7001 fasted in Period
1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
15 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
79 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
2 Participants
n=18 Participants
|
45 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
25 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
91 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
2 Participants
n=18 Participants
|
33 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
21 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
3 Participants
n=18 Participants
|
102 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
20 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
20 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=73 Participants
|
3 Participants
n=18 Participants
|
107 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=20 Participants
|
0 participants
n=20 Participants
|
0 participants
n=40 Participants
|
0 participants
n=5 Participants
|
0 participants
n=9 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=5 Participants
|
1 participants
n=6 Participants
|
12 participants
n=4 Participants
|
0 participants
n=4 Participants
|
0 participants
n=4 Participants
|
0 participants
n=73 Participants
|
0 participants
n=18 Participants
|
13 participants
n=18 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=20 Participants
|
7 participants
n=20 Participants
|
6 participants
n=40 Participants
|
6 participants
n=5 Participants
|
8 participants
n=9 Participants
|
5 participants
n=6 Participants
|
6 participants
n=6 Participants
|
23 participants
n=6 Participants
|
11 participants
n=5 Participants
|
5 participants
n=6 Participants
|
13 participants
n=4 Participants
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
4 participants
n=73 Participants
|
3 participants
n=18 Participants
|
111 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Screening to end of study (28-35 calendar days after end of treatment). End of treatment at disease progression, unacceptable toxicity or withdrawal of consent. Average time on study 142.6 days (range 9 - 1135 days)Population: Results are presented for Participants with one or more related TEAEs. Module 4 crossover cohorts are presented in terms of patients fed/fasted correctly in accordance with the protocol. One participant in 120mg OD Fed cohort deviated from the protocol and data for this participant is therefore reported under 120mg Fasted cohort.
Treatment-emergent adverse events (TEAEs) are defined as those AEs which occur from Cycle 0 Day 1/Cycle 1 Day 1 of the study module to 28 days after the last dose of CT7001 in a module. Results reported below for Participants with one or more related TEAEs.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=7 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=8 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=6 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=23 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
n=6 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
n=25 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
n=6 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
n=7 Participants
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)
|
11 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
6 Participants
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22 Participants
|
6 Participants
|
24 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: After the first dose and during the dosing period (from the time of dose administration to 24 hours) for Module 1A cohorts. Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 120 and 168 hours post dose for Module 4 Cohorts.Population: Cmax presented for Module 1A cohorts 1-5 and Module 4 crossover cohorts. Module 1A paired biopsy cohorts (240mg OD and 360mg OD) results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results respectively and in accordance with pre-specified SAP. Cmax was not required in accordance with pre-specified SAP for Module 1B-1, 1B-2, Module 2A and Module 4 continuous dose cohorts.
Cmax is the maximum observed plasma concentration of CT7001 following oral dosing.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=7 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=5 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=9 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=1 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=8 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=3 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=6 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=8 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=6 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of CT7001 (Cmax)
|
176.1 ng/mL
Geometric Coefficient of Variation 63.91
|
89.15 ng/mL
Geometric Coefficient of Variation 106.9
|
201.4 ng/mL
Geometric Coefficient of Variation 22.25
|
172.8 ng/mL
Geometric Coefficient of Variation NA
"NA" indicates that data could not be evaluated due to smaller number of participants.
|
270.2 ng/mL
Geometric Coefficient of Variation 45.69
|
233.3 ng/mL
Geometric Coefficient of Variation 28.75
|
19.21 ng/mL
Geometric Coefficient of Variation 149.1
|
63.77 ng/mL
Geometric Coefficient of Variation 108.8
|
138.8 ng/mL
Geometric Coefficient of Variation 19.72
|
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SECONDARY outcome
Timeframe: After the first dose and during the dosing period (from the time of dose administration to 24 hours) for Module 1A. Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 120 and 168 hours post dose for Module 4 Cohorts.Population: AUC presented for Module 1A cohorts 1-5 and Module 4 crossover cohorts. Module 1A paired biopsy cohorts (240mg OD and 360mg OD) results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results respectively and in accordance with pre-specified SAP. AUC was not required in accordance with pre-specified SAP for Module 1B-1, 1B-2, Module 2A and Module 4 continuous dose cohorts.
Area under the plasma concentration-time curve representing the total drug exposure over time.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=7 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=5 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=9 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=1 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=8 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=3 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=3 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=7 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=5 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC)
|
2545 h*ng/mL
Geometric Coefficient of Variation 66.10
|
802.9 h*ng/mL
Geometric Coefficient of Variation 83.83
|
1926 h*ng/mL
Geometric Coefficient of Variation 18.75
|
2506 h*ng/mL
Geometric Coefficient of Variation NA
"NA" indicates that data could not be evaluated due to smaller number of participants
|
2791 h*ng/mL
Geometric Coefficient of Variation 27.63
|
1377 h*ng/mL
Geometric Coefficient of Variation 15.21
|
785.3 h*ng/mL
Geometric Coefficient of Variation 14.26
|
694.9 h*ng/mL
Geometric Coefficient of Variation 55.93
|
2696 h*ng/mL
Geometric Coefficient of Variation 41.38
|
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SECONDARY outcome
Timeframe: From enrolment (Day 1) through to disease progression, unacceptable toxicity or withdrawal of consent, whichever came first (EOT). Assessed up to 1135 days. On study pre-dose sampling for all modules (see outcome measure description).Population: Mean trough plasma PK concentration (CT7001) presented for Module 1A cohorts 1-5, Module 1 B-1, Module 1B-2, Module 2A 360mg \& Module 4 (continuous dose) cohorts. M1A paired biopsy cohorts (240mg OD \& 360mg OD) results are included within M1A cohort 2 (240mg OD) \& cohort 4 (360mg OD) results respectively \& in accordance with pre-specified SAP. M2A 240mg could not be calculated due to insufficient blood sample volume collected. M 4 crossover cohorts are not reported in accordance with the SAP.
Mean Trough Plasma Pharmacokinetic Concentrations is the lowest concentration of a drug in the bloodstream during a dosing interval. Timeframe: On study sampling: M1A - Day 1, 8, 15, 22, 29, 43, 50, every 21 days thereafter and EOT. M1B-1 and M1B-2: Day1, 8, 22, every 21 days thereafter and EOT. M2A: Day1, 15, 29, 57, every 56 days thereafter and EOT. M4: Day 1, 8, 15, 22, 29, 36, every 21 days thereafter and EOT.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=25 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=5 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=9 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=1 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=12 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=8 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=23 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=11 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=6 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
n=8 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
n=7 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Trough Plasma Pharmacokinetic Concentrations for CT7001
|
68.97 ng/mL
Geometric Coefficient of Variation 69.2
|
16.12 ng/mL
Geometric Coefficient of Variation 71.17
|
44.60 ng/mL
Geometric Coefficient of Variation 32.05
|
60.60 ng/mL
Geometric Coefficient of Variation NA
NA indicates that data could not be evaluated due to smaller number of participants
|
63.40 ng/mL
Geometric Coefficient of Variation 47.89
|
55.91 ng/mL
Geometric Coefficient of Variation 78.90
|
39.22 ng/mL
Geometric Coefficient of Variation 41.48
|
41.56 ng/mL
Geometric Coefficient of Variation 47.94
|
NA ng/mL
Geometric Coefficient of Variation NA
NA indicates that data could not be evaluated due to insufficient blood volume.
|
47.87 ng/mL
Geometric Coefficient of Variation 41.44
|
34.26 ng/mL
Geometric Coefficient of Variation 138.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrolment through to disease progression, unacceptable toxicity or withdrawal of consent, whichever came first (EOT). Pre-dose sampling at Day 1, 15, 29, 57 and every 56 days thereafter and EOT. Assessed up to 848 days.Population: Mean Trough Plasma Pharmacokinetic Concentration under this outcome measure are presented for Module 2A cohorts for fulvestrant. Mean Trough Plasma Pharmacokinetic Concentration for CT7001 are presented for M1A 1-5 cohorts (including paired biopsy cohorts), M 1B-1, 1B-2, M 2A 360mg and M4 in a separate outcome measure under "Trough plasma concentration for CT7001".
Mean trough plasma PK concentrations refer to the lowest concentration of a drug in the bloodstream during a dosing interval.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=25 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Trough Plasma Pharmacokinetic Concentrations for Fulvestrant (Module 2A)
|
—
|
12.65 ng/mL
Geometric Coefficient of Variation 13.88
|
12.47 ng/mL
Geometric Coefficient of Variation 36.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1135 days (162 weeks). Frequency in outcome measure description.Population: Best Objective Response (BOR) presented for Module 1A all cohorts, Module 1 B-1, Module 1B-2, Module 2A and Module 4 (continuous dose) cohorts. Module 4-120mg OD Fed, Module 4 120mg OD Fasted, Module 4 360mg OD Fed and Module 4 360mg OD Fasted are not reported as was pre-specified by the Statistical Analysis Plan. The BOR for these patients are reported under the continuous dosing results. Module 2A 360mg cohort has 19/25 patients in the evaluable for response population.
Antitumour activity endpoints were analysed using the evaluable for Response population (any patient with at least one post baseline RECIST assessment). Best objective response is defined as the best response recorded from the start of study treatment to the end of treatment, including any assessments for confirmation after the end of treatment. Percentage of participants with each response calculated was based on the total number of participants with a baseline RECIST assessment. Timeframe: Scan frequency - Modules 1A and 4 (every 6 weeks); Modules 1B-1 and 2A (every 8 weeks first year, every 12 weeks thereafter); Module 1B-2 (every 8 weeks for the 6 months, every 12 weeks thereafter).
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=5 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=2 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=7 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=23 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
n=6 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
n=19 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Complete response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
|
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Partial response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
|
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Not evaluable
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
|
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Stable disease
|
5 participants
|
2 participants
|
3 participants
|
0 participants
|
4 participants
|
4 participants
|
2 participants
|
3 participants
|
11 participants
|
3 participants
|
10 participants
|
—
|
—
|
—
|
—
|
5 participants
|
4 participants
|
|
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Progressive disease
|
5 participants
|
4 participants
|
2 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
2 participants
|
8 participants
|
2 participants
|
7 participants
|
—
|
—
|
—
|
—
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first. Modules 1B-1 and 2A: every 8 weeks first year, every 12 weeks thereafter) assessed up to 848 days (121 weeks).Population: PFS is presented for Modules 1B-1 and Module 2A cohorts. Following a review of the data, the PFS endpoint was deemed clinically non-informative for Module 1A, Module 1B-2 and Module 4 cohorts due to the limited number of patients in each module/cohort and was excluded from the final analysis.
Antitumour activity endpoints were analysed using the evaluable for Response population based on RECIST assessment. Progression free survival is defined as the time from start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant had withdrawn from therapy or had received another anti-cancer therapy prior to progression. Participants who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=5 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=2 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=7 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=6 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
n=6 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
n=25 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
n=6 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
n=7 Participants
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-tumour Activity According to RECIST v1.1-Progression Free Survival
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
72 days
Interval 56.0 to 113.0
|
107 days
Interval 51.0 to
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
114 days
Interval 56.0 to 421.0
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
NA days
"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
|
SECONDARY outcome
Timeframe: From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first. Module 2A: every 8 weeks first year, every 12 weeks thereafter) assessed up to 848 days (121 weeks).Population: Clinical Benefit Rate (CBR) is defined as the percentage of subjects with a confirmed objective response of complete response or partial response, or stabilisation of disease for at least 24 weeks CBR is analysed using the evaluable for response population (any patient with at least one post baseline RECIST assessment). CBR is presented Module 2A only. Modules 1A, 1B-1, 1B-2 and 4 were excluded from the final analysis due to the low number in evaluable for response population.
Antitumour activity endpoints were analysed using the evaluable for Response population based on RECIST assessment. Clinical Benefit Rate (CBR) is defined as the percentage of subjects with a confirmed objective response of complete response or partial response, or stabilisation of disease for at least 24 weeks.
Outcome measures
| Measure |
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 Participants
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 PartA-Cohort 1 120mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=5 Participants
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=2 Participants
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=6 Participants
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
|
Module 1 Part A-Cohort 5 180mg BID
n=7 Participants
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
n=5 Participants
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=23 Participants
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2A 240 mg OD
n=6 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2A 360 mg OD
n=19 Participants
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120 mg OD Fed
n=6 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 120mg OD Fasted
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
|
Module 4 360 mg OD Fed
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
|
Module 4 360mg OD Fasted
n=7 Participants
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
|
Module 4 240 mg OD Continuous Dosing
n=8 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
|
Module 4 360 mg OD Continuous Dosing
n=7 Participants
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-tumour Activity According to RECIST v1.1-Clinical Benefit Rate (CBR)
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
16.7 percentage of subjects
|
42.1 percentage of subjects
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
NA percentage of subjects
"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
|
Adverse Events
Module 1 Part A-Cohort 1 120mg OD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Module 1 Part A-Cohort 2 240mg OD
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Module 1 Part A-Cohort 3 480mg OD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Module 1 Part A-Cohort 4 360mg OD
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Module 1 Part A-Cohort 5 180mg BID
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Serious events: 9 serious events
Other events: 23 other events
Deaths: 2 deaths
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Module 2 Part A CT7001 240mg OD + Fulvestrant (Cohort 1)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Module 2 Part A CT7001 360mg OD + Fulvestrant (Cohort 2)
Serious events: 8 serious events
Other events: 25 other events
Deaths: 1 deaths
Module 4 120mg OD Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Module 4 120mg OD Fasted
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Module 4 360mg OD Fed
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 4 360mg OD Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 4 240mg OD Continuous Dosing
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Module 4 360mg OD Continous Dosing
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Module 1 Part A-Cohort 1 120mg OD
n=6 participants at risk
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=12 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=6 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=12 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 5 180mg BID
n=8 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=23 participants at risk
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 participants at risk
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2 Part A CT7001 240mg OD + Fulvestrant (Cohort 1)
n=6 participants at risk
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2 Part A CT7001 360mg OD + Fulvestrant (Cohort 2)
n=25 participants at risk
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120mg OD Fed
n=6 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fed data combined and presented for Sequence 1, Period 1 and Sequence 2, Period 2.
|
Module 4 120mg OD Fasted
n=8 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fasted data combined and presented for Sequence 1, Period 2 and Sequence 2, Period 1.
|
Module 4 360mg OD Fed
n=7 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fed data combined and presented for Sequence 3, Period 1 and Sequence 4, Period 2.
|
Module 4 360mg OD Fasted
n=7 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fasted data combined and presented for Sequence 3, Period 2 and Sequence 4, Period 1.
|
Module 4 240mg OD Continuous Dosing
n=8 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 240mg OD continuous dosing data combined and presented for Sequence 1 and Sequence 2 participants.
|
Module 4 360mg OD Continous Dosing
n=7 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg OD continuous dosing data combined and presented for Sequence 3 and Sequence 4 participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Disease progression
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm muscle weakness
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
Other adverse events
| Measure |
Module 1 Part A-Cohort 1 120mg OD
n=6 participants at risk
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 2 240mg OD
n=12 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 3 480mg OD
n=6 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part A-Cohort 4 360mg OD
n=12 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
|
Module 1 Part A-Cohort 5 180mg BID
n=8 participants at risk
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
|
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
n=23 participants at risk
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
n=11 participants at risk
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
|
Module 2 Part A CT7001 240mg OD + Fulvestrant (Cohort 1)
n=6 participants at risk
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 2 Part A CT7001 360mg OD + Fulvestrant (Cohort 2)
n=25 participants at risk
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
|
Module 4 120mg OD Fed
n=6 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fed data combined and presented for Sequence 1, Period 1 and Sequence 2, Period 2.
|
Module 4 120mg OD Fasted
n=8 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fasted data combined and presented for Sequence 1, Period 2 and Sequence 2, Period 1.
|
Module 4 360mg OD Fed
n=7 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fed data combined and presented for Sequence 3, Period 1 and Sequence 4, Period 2.
|
Module 4 360mg OD Fasted
n=7 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fasted data combined and presented for Sequence 3, Period 2 and Sequence 4, Period 1.
|
Module 4 240mg OD Continuous Dosing
n=8 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 240mg OD continuous dosing data combined and presented for Sequence 1 and Sequence 2 participants.
|
Module 4 360mg OD Continous Dosing
n=7 participants at risk
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg OD continuous dosing data combined and presented for Sequence 3 and Sequence 4 participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
41.7%
5/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
27.3%
3/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.0%
3/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
36.4%
4/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
3/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
4/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
30.4%
7/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
24.0%
6/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
50.0%
4/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.6%
2/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
41.7%
5/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
26.1%
6/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.0%
7/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
20.0%
5/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
6/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
66.7%
8/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
100.0%
6/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
100.0%
12/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
62.5%
5/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
91.3%
21/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
90.9%
10/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
66.7%
4/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
92.0%
23/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.6%
2/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
42.9%
3/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
87.5%
7/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
85.7%
6/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Hypoaesthesia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
75.0%
9/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
50.0%
3/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
91.7%
11/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
75.0%
6/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
95.7%
22/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
72.7%
8/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
100.0%
6/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
76.0%
19/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
37.5%
3/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.6%
2/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
87.5%
7/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
57.1%
4/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
13.0%
3/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
75.0%
9/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
100.0%
6/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
83.3%
10/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
87.5%
7/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
60.9%
14/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
54.5%
6/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
100.0%
6/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
72.0%
18/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.6%
2/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
62.5%
5/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
57.1%
4/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Biliary tract infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Chills
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Crepitations
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Disease progression
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Facial pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Fatigue
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
58.3%
7/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
50.0%
6/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
47.8%
11/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
50.0%
3/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
44.0%
11/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
75.0%
6/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.6%
2/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Injection site brusing
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Fungal infection
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.0%
3/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Burn oral cavity
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
4/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
20.0%
5/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
20.0%
5/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Blood creatinine phosphokinase increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Hyperphosphataemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
20.0%
5/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
General disorders
Chest pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
3/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
13.0%
3/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
54.5%
6/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
44.0%
11/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
37.5%
3/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
28.6%
2/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.0%
3/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
20.0%
5/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.0%
3/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
66.7%
4/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Neuralgia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.0%
4/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.0%
3/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
27.3%
3/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
4/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
37.5%
3/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
13.0%
3/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
37.5%
3/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
18.2%
2/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Infections and infestations
Upper respiratory tract infection
|
83.3%
5/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.7%
2/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.0%
2/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.3%
1/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
20.0%
5/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
14.3%
1/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
25.0%
2/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Surgical and medical procedures
Chest tube insertion
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
2/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
33.3%
2/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Reproductive system and breast disorders
Menorrhagia
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
Lymph node palpable
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
16.7%
1/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
8.3%
1/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
12.5%
1/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
4.0%
1/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/12 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/23 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
9.1%
1/11 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/25 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/6 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/8 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
0.00%
0/7 • SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place