Trial Outcomes & Findings for Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML (NCT NCT05020665)
NCT ID: NCT05020665
Last Updated: 2024-01-10
Results Overview
MRD negative CR requires CR as defined by the European Leukemia Network (ELN) 2017 criteria (with minor modification for neutrophil and platelet count thresholds as defined by International Working Group \[IWG\]) as assessed by study site investigators, and MRD negativity (\<0.01%) in bone marrow as measured by a molecular nucleophosmin-1 mutated (NPM1-m) assay (eg, next generation sequencing) in a central laboratory upon recovery of peripheral blood counts following completion of 2 cycles of chemotherapy, no later than Day 42 of Cycle 2.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
Cycle 1 Day 1, up to Day 42 of chemotherapy cycle 2 (Cycle length = 42 days)
Results posted on
2024-01-10
Participant Flow
Participants were enrolled from 5 countries including the Czechia, France, Republic of Korea, Spain, and the United States from 24 November 2021 to 30 March 2023.
In this study participants were randomized 1:1 to receive intensive chemotherapy in combination with either the spleen tyrosine kinase inhibitor, entospletinib (ENTO), or placebo. Randomization was stratified by age (\< 60 vs ≥ 60 years) and anthracycline administered during induction (daunorubicin vs idarubicin). In November 2022, the Sponsor decided to terminate this study prior to full enrollment.
Participant milestones
| Measure |
ENTO
Participants received ENTO twice daily (BID), along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline)
|
Placebo
Participants received placebo BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
ENTO
Participants received ENTO twice daily (BID), along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline)
|
Placebo
Participants received placebo BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline)
|
|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
5
|
4
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Reason not specified
|
1
|
0
|
Baseline Characteristics
Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
Baseline characteristics by cohort
| Measure |
ENTO
n=8 Participants
Participants received ENTO twice daily (BID), along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline).
|
Placebo
n=7 Participants
Participants received placebo BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline).
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
54.6 Years
STANDARD_DEVIATION 16.11 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, up to Day 42 of chemotherapy cycle 2 (Cycle length = 42 days)Population: Data not collected as the study was terminated early.
MRD negative CR requires CR as defined by the European Leukemia Network (ELN) 2017 criteria (with minor modification for neutrophil and platelet count thresholds as defined by International Working Group \[IWG\]) as assessed by study site investigators, and MRD negativity (\<0.01%) in bone marrow as measured by a molecular nucleophosmin-1 mutated (NPM1-m) assay (eg, next generation sequencing) in a central laboratory upon recovery of peripheral blood counts following completion of 2 cycles of chemotherapy, no later than Day 42 of Cycle 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1, up to Day 42 of chemotherapy cycle 2 (Cycle length = 42 days)Population: Data not collected as the study was terminated early.
EFS is defined as the time from randomization to the earliest occurrence of induction treatment failure, relapse from CR, or death from any cause. Induction treatment failure is failure to achieve morphological CR after completion of the last cycle of induction chemotherapy (no later than Day 42 of the last cycle of induction).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1, up to Day 42 of chemotherapy cycle 2 (Cycle length = 42 days)Population: Data not collected as the study was terminated early.
RFS is defined as the time from CR until relapse or death from any cause as assessed by study site investigators.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1, up to Day 42 of chemotherapy cycle 2 (Cycle length = 42 days)Population: Data not collected as the study was terminated early.
OS is defined as the time from randomization until death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1, up to Day 42 of chemotherapy cycle 2 (Cycle length = 42 days)Population: Intent-to-Treat (ITT) Analysis Set: All participants who were randomized.
CR as defined by ELN 2017 criteria (with minor modification for neutrophil and platelet count thresholds as defined by IWG) as assessed by study site investigators.
Outcome measures
| Measure |
ENTO
n=8 Participants
Participants received ENTO BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous IV infusion (cytarabine) or slow IV push (anthracycline).
|
Placebo
n=7 Participants
Participants received placebo, BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous IV infusion (cytarabine) or slow IV push (anthracycline).
|
|---|---|---|
|
Number of Participant With Complete Response (CR) After 2 Cycles of Chemotherapy
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to 30 days following study treatment completion, (Cycle length = 42 days) maximum up to 198 daysPopulation: Safety Analysis Set: All participants randomized who received at least one dose of study medication.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA). Clinically significant changes in safety laboratory assessments, electrocardiograms, echocardiogram / multi-gated acquisition scans and Eastern Cooperative Oncology Group performance status findings, as assessed by the Investigator, were recorded as TEAEs.
Outcome measures
| Measure |
ENTO
n=8 Participants
Participants received ENTO BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous IV infusion (cytarabine) or slow IV push (anthracycline).
|
Placebo
n=7 Participants
Participants received placebo, BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous IV infusion (cytarabine) or slow IV push (anthracycline).
|
|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
8 Participants
|
7 Participants
|
Adverse Events
ENTO
Serious events: 8 serious events
Other events: 7 other events
Deaths: 3 deaths
Placebo
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ENTO
n=8 participants at risk
Participants received ENTO twice daily (BID), along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline).
|
Placebo
n=7 participants at risk
Participants received placebo BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline).
|
|---|---|---|
|
Infections and infestations
Klebsiella bacteraemia
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Sepsis
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Anorectal infection
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Clostridium colitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Enterobacter sepsis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Fungal sepsis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Pneumonia fungal
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Pneumonia legionella
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Septic shock
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Vulvitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
28.6%
2/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Colitis
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
Other adverse events
| Measure |
ENTO
n=8 participants at risk
Participants received ENTO twice daily (BID), along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline).
|
Placebo
n=7 participants at risk
Participants received placebo BID, along with intensive chemotherapy (cytarabine and anthracycline) by continuous intravenous (IV) infusion (cytarabine) or slow IV push (anthracycline).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8 • Number of events 5 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
28.6%
2/7 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 5 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Colitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Haemorrhoids
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
2/8 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
71.4%
5/7 • Number of events 7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
4/8 • Number of events 29 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 34 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • Number of events 36 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 25 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
2/8 • Number of events 19 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 20 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 16 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Fatigue
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Chills
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
28.6%
2/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Asthenia
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Deformity
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
General physical health deterioration
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Medical device site haemorrhage
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
General disorders
Pain
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Cellulitis
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
COVID-19
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Gastrointestinal infection
|
25.0%
2/8 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Klebsiella bacteraemia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Clostridium colitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Gingivitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Herpes simplex reactivation
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
2/8 • Number of events 12 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Number of events 15 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
42.9%
3/7 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
28.6%
2/7 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Amylase increased
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
28.6%
2/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
C-reactive protein increased
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Lipase increased
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 4 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Investigations
Transaminases increased
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 3 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Cytarabine syndrome
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
28.6%
2/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
14.3%
1/7 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Renal and urinary disorders
Renal cyst
|
25.0%
2/8 • Number of events 2 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Hepatobiliary disorders
Hepatic cyst
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Eye disorders
Keratitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
0.00%
0/7 • Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place