Trial Outcomes & Findings for Dose Escalation Study With Expansion to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of CCT3833 (NCT NCT02437227)
NCT ID: NCT02437227
Last Updated: 2026-05-12
Results Overview
Number of patients with DLT in each cohort/dose level. The maximum tolerated dose is the dose at which no more than one patient out of up to six patients at the same dose level experience a highly probably or probably drug-related DLT as defined in the protocol.
COMPLETED
PHASE1
31 participants
Patients were assessed for DLTs from trial treatment start (cycle 1 day 1) through each of the treatment (28 days) cycles until the patients' final safety follow up at 30 days after last dose for up to 18 months.
2026-05-12
Participant Flow
Study opened on 15/04/2015 to recruit 31 patients at two sites (Royal Marsden and Christie).
Participant milestones
| Measure |
Experiment - CCT3833 Cohort 1
Part A - Dose escalation stage - Dose level 1 : 20mg
|
Experiment - CCT3833 Cohort 2
Part A - Dose escalation stage - Dose level 2 : 40mg
|
Experiment - CCT3833 Cohort 3
Part A - Dose escalation stage - Dose level 3 : 75mg
|
Experiment - CCT3833 Cohort 4
Part A - Dose escalation stage - Dose level 4 : 150mg
|
Experiment - CCT3833 Cohort 5
Part A - Dose escalation stage - Dose level 5 : 300mg
|
Experiment - CCT3833 Cohort 6
Part A - Dose escalation stage - Dose level 6 : 600mg
|
Experiment - CCT3833 Cohort 7
Part A - Dose escalation stage - Dose level 7 : 900mg
|
Experiment - CCT3833 Cohort 8
Part A - Dose escalation stage - Dose level 8 : 1350mg
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
4
|
6
|
4
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
4
|
6
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Escalation Study With Expansion to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of CCT3833
Baseline characteristics by cohort
| Measure |
Experiment - CCT3833 Cohort 1
n=3 Participants
Part A - Dose escalation stage -Dose level 1 : 20mg
|
Experiment - CCT3833 Cohort 2
n=3 Participants
Part A - Dose escalation stage -Dose level 2 : 40mg
|
Experiment - CCT3833 Cohort 3
n=3 Participants
Part A - Dose escalation stage -Dose level 3 : 75mg
|
Experiment - CCT3833 Cohort 4
n=3 Participants
Part A - Dose escalation stage -Dose level 4 : 150mg
|
Experiment - CCT3833 Cohort 5
n=4 Participants
Part A - Dose escalation stage -Dose level 5 : 300mg
|
Experiment - CCT3833 Cohort 6
n=6 Participants
Part A - Dose escalation stage -Dose level 6 : 600mg
|
Experiment - CCT3833 Cohort 7
n=4 Participants
Part A - Dose escalation stage -Dose level 7 : 900mg
|
Experiment - CCT3833 Cohort 8
n=5 Participants
Part A - Dose escalation stage -Dose level 8 : 1350mg
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.84 years
STANDARD_DEVIATION 10.50 • n=1512 Participants
|
58.86 years
STANDARD_DEVIATION 14.63 • n=504 Participants
|
66.40 years
STANDARD_DEVIATION 9.76 • n=2016 Participants
|
61.80 years
STANDARD_DEVIATION 3.54 • n=99 Participants
|
56.51 years
STANDARD_DEVIATION 2.12 • n=97 Participants
|
49.15 years
STANDARD_DEVIATION 8.75 • n=488 Participants
|
60.64 years
STANDARD_DEVIATION 15.83 • n=70 Participants
|
46.30 years
STANDARD_DEVIATION 13.25 • n=40 Participants
|
54.93 years
STANDARD_DEVIATION 11.72 • n=295 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
5 Participants
n=488 Participants
|
2 Participants
n=70 Participants
|
3 Participants
n=40 Participants
|
15 Participants
n=295 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
4 Participants
n=97 Participants
|
1 Participants
n=488 Participants
|
2 Participants
n=70 Participants
|
2 Participants
n=40 Participants
|
16 Participants
n=295 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African/Caribbean
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=295 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
4 Participants
n=97 Participants
|
6 Participants
n=488 Participants
|
4 Participants
n=70 Participants
|
5 Participants
n=40 Participants
|
30 Participants
n=295 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=1512 Participants
|
3 participants
n=504 Participants
|
3 participants
n=2016 Participants
|
3 participants
n=99 Participants
|
4 participants
n=97 Participants
|
6 participants
n=488 Participants
|
4 participants
n=70 Participants
|
5 participants
n=40 Participants
|
31 participants
n=295 Participants
|
PRIMARY outcome
Timeframe: Patients were assessed for DLTs from trial treatment start (cycle 1 day 1) through each of the treatment (28 days) cycles until the patients' final safety follow up at 30 days after last dose for up to 18 months.Population: Intention to treat (ITT) population. Patients were enrolled and treated in the Part A dose escalation stage only.
Number of patients with DLT in each cohort/dose level. The maximum tolerated dose is the dose at which no more than one patient out of up to six patients at the same dose level experience a highly probably or probably drug-related DLT as defined in the protocol.
Outcome measures
| Measure |
Experiment - CCT3833 Cohort 1
n=3 Participants
Part A - Dose escalation stage - Dose level 1: 20mg
|
Experiment - CCT3833 Cohort 2
n=3 Participants
Part A - Dose escalation stage - Dose level 2: 40mg
|
Experiment - CCT3833 Cohort 3
n=3 Participants
Part A - Dose escalation stage - Dose level 3: 75mg
|
Experiment - CCT3833 Cohort 4
n=3 Participants
Part A - Dose escalation stage - Dose level 4: 150mg
|
Experiment - CCT3833 Cohort 5
n=4 Participants
Part A - Dose escalation stage - Dose level 5: 300mg
|
Experiment - CCT3833 Cohort 6
n=6 Participants
Part A - Dose escalation stage - Dose level 6: 600mg
|
Experiment - CCT3833 Cohort 7
n=4 Participants
Part A - Dose escalation stage - Dose level 7: 900mg
|
Experiment - CCR3833 Cohort 8
n=5 Participants
Part A - Dose escalation stage - Dose level 8: 1350mg
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Patients With Dose Limiting Toxicities (DLT).
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose for up to 18 months.Population: Intention to treat (ITT) all patients recruited and stated treatment.
Determining causality of each adverse event (AE) to CCT3833 and grade according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Experiment - CCT3833 Cohort 1
n=3 Participants
Part A - Dose escalation stage - Dose level 1: 20mg
|
Experiment - CCT3833 Cohort 2
n=3 Participants
Part A - Dose escalation stage - Dose level 2: 40mg
|
Experiment - CCT3833 Cohort 3
n=3 Participants
Part A - Dose escalation stage - Dose level 3: 75mg
|
Experiment - CCT3833 Cohort 4
n=3 Participants
Part A - Dose escalation stage - Dose level 4: 150mg
|
Experiment - CCT3833 Cohort 5
n=4 Participants
Part A - Dose escalation stage - Dose level 5: 300mg
|
Experiment - CCT3833 Cohort 6
n=6 Participants
Part A - Dose escalation stage - Dose level 6: 600mg
|
Experiment - CCT3833 Cohort 7
n=4 Participants
Part A - Dose escalation stage - Dose level 7: 900mg
|
Experiment - CCR3833 Cohort 8
n=5 Participants
Part A - Dose escalation stage - Dose level 8: 1350mg
|
|---|---|---|---|---|---|---|---|---|
|
Assessing the Safety and Tolerability Profile of CCT3833. (Adverse Event)
Patients with any toxicities grade 3 and above
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Assessing the Safety and Tolerability Profile of CCT3833. (Adverse Event)
Patients with any toxicities grade 1 and above
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
Experiment - CCT3833 Cohort 1
Experiment - CCT3833 Cohort 2
Experiment - CCT3833 Cohort 3
Experiment - CCT3833 Cohort 4
Experiment - CCT3833 Cohort 5
Experiment - CCT3833 Cohort 6
Experiment - CCT3833 Cohort 7
Experiment - CCT3833 Cohort 8
Serious adverse events
| Measure |
Experiment - CCT3833 Cohort 1
n=3 participants at risk
Part A - Dose escalation stage: Dose level 1: 20mg
|
Experiment - CCT3833 Cohort 2
n=3 participants at risk
Part A - Dose escalation stage: Dose level 2: 40mg
|
Experiment - CCT3833 Cohort 3
n=3 participants at risk
Part A - Dose escalation stage: Dose level 3: 75mg
|
Experiment - CCT3833 Cohort 4
n=3 participants at risk
Part A - Dose escalation stage: Dose level 4: 150mg
|
Experiment - CCT3833 Cohort 5
n=4 participants at risk
Part A - Dose escalation stage: Dose level 5: 300mg
|
Experiment - CCT3833 Cohort 6
n=6 participants at risk
Part A - Dose escalation stage: Dose level 6: 600mg
|
Experiment - CCT3833 Cohort 7
n=4 participants at risk
Part A - Dose escalation stage: Dose level 7: 900mg
|
Experiment - CCT3833 Cohort 8
n=5 participants at risk
Part A - Dose escalation stage: Dose level 8: 1350mg
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Colonic obstruction
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
General disorders
Fever
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
2/6 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Blood and lymphatic system disorders
Other
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
Other adverse events
| Measure |
Experiment - CCT3833 Cohort 1
n=3 participants at risk
Part A - Dose escalation stage: Dose level 1: 20mg
|
Experiment - CCT3833 Cohort 2
n=3 participants at risk
Part A - Dose escalation stage: Dose level 2: 40mg
|
Experiment - CCT3833 Cohort 3
n=3 participants at risk
Part A - Dose escalation stage: Dose level 3: 75mg
|
Experiment - CCT3833 Cohort 4
n=3 participants at risk
Part A - Dose escalation stage: Dose level 4: 150mg
|
Experiment - CCT3833 Cohort 5
n=4 participants at risk
Part A - Dose escalation stage: Dose level 5: 300mg
|
Experiment - CCT3833 Cohort 6
n=6 participants at risk
Part A - Dose escalation stage: Dose level 6: 600mg
|
Experiment - CCT3833 Cohort 7
n=4 participants at risk
Part A - Dose escalation stage: Dose level 7: 900mg
|
Experiment - CCT3833 Cohort 8
n=5 participants at risk
Part A - Dose escalation stage: Dose level 8: 1350mg
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
3/3 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
3/6 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
80.0%
4/5 • Number of events 8 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Bloating
|
66.7%
2/3 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 10 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
2/6 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
60.0%
3/5 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
3/6 • Number of events 14 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
40.0%
2/5 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 7 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
4/6 • Number of events 7 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
75.0%
3/4 • Number of events 18 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
40.0%
2/5 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
2/6 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
General disorders
Edema limbs
|
66.7%
2/3 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 9 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
60.0%
3/5 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
40.0%
2/5 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
General disorders
Pain
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
75.0%
3/4 • Number of events 11 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
80.0%
4/5 • Number of events 12 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
75.0%
3/4 • Number of events 7 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 8 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
80.0%
4/5 • Number of events 11 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
60.0%
3/5 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Investigations
CPK increased
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
50.0%
2/4 • Number of events 13 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
40.0%
2/5 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 7 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 10 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
40.0%
2/5 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
60.0%
3/5 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
2/6 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
60.0%
3/5 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
2/6 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 7 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 8 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 12 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
40.0%
2/5 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 12 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
66.7%
2/3 • Number of events 6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 18 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 2 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
16.7%
1/6 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
33.3%
1/3 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 7 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
Skin and subcutaneous tissue disorders
Other
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
75.0%
3/4 • Number of events 5 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 14 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
|
General disorders
Other
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/3 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/4 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
0.00%
0/6 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
25.0%
1/4 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
20.0%
1/5 • Number of events 1 • AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose up to 18 months. All cause of mortality is recorded until death or end of trial (36 months).
An adverse event (AE) is any untoward, undesired or unplanned occurrence in a patient administered an IMP, a comparator product or an approved drug. An AE can be a sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the CCT3833 or comparator.
|
Additional Information
PANRAF Trial Manager
The Royal Marsden NHS Foundation Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place