Trial Outcomes & Findings for A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT00620321)
NCT ID: NCT00620321
Last Updated: 2019-09-09
Results Overview
Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Start of treatment to study completion up to 6.7 months
Results posted on
2019-09-09
Participant Flow
The reasons for discontinuation listed in the Participant Flow are the reasons the participant discontinued treatment. All participants who have completed at least 1 cycle of study drug were considered to have completed the study.
Participant milestones
| Measure |
LY2181308
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
16
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
8
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
16
|
Reasons for withdrawal
| Measure |
LY2181308
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
7
|
|
Overall Study
Progressive Disease
|
5
|
5
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 Participants
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.26 years
STANDARD_DEVIATION 15.93 • n=39 Participants
|
48.22 years
STANDARD_DEVIATION 14.72 • n=41 Participants
|
52.23 years
STANDARD_DEVIATION 15.88 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
African
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to study completion up to 6.7 monthsPopulation: All participants who received at least one dose of study drug.
Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section.
Outcome measures
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 Participants
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Number of Participants With Adverse Events (Safety Profile)
SAE
|
6 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (Safety Profile)
Drug-related TEAE
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to progression of disease or death up to 6 monthsPopulation: All participants who received at least one dose of study drug.
Response is complete remission (CR) + CR with incomplete blood count recovery (CRi) + partial remission (PR) + cytoreduction. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). Response rate is calculated as a total number of participants with CR or CRi or PR or cytoreduction divided by the total number of participants treated multiplied by 100.
Outcome measures
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 Participants
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates)
|
0 percentage of participants
|
56.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to progression of disease or death up to 6 monthsPopulation: Zero participants analyzed as no data collected on participants for relapse free survival due to no sufficient follow up on participants with response for time to event.
Relapse-Free Survival was defined as the time from first objective status assessment of complete remission (CR) or CR with incomplete blood count recovery (CRi) or partial remission (PR) or cytoreduction to the first time of disease progression or death as a result of any cause. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). There were too few participants who had a documented progression of disease or death event amongst the participants with a response of CR, CRi, PR or cytoreduction to conduct the time-to-event analysis, thus the relapse-free survival was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3: 0,12,24,36,48,60,72,84,96,108,120,132 hoursPopulation: All participants who received study drug and had pharmacokinetic (PK) data to calculate AUC.
Area under the curve of LY2181308 over the dosing interval
Outcome measures
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 Participants
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Area Under the Curve of LY2181308 Over the Dosing Interval
|
216947 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 60.0
|
185734 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 45.7
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All participants who received at least one dose of study drug. Per protocol amendment, Survivin Protein Expression change was assessed for LY2181308 arm only.
Pharmacodynamics: Number of participants with Survivin Protein Expression.
Outcome measures
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Pharmacodynamics: Number of Participants With Survivin Protein Expression
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2Population: All participants who received at least one dose of study drug and had both baseline and Day 2 survivin index measurements. Per protocol amendment, only participants in LY2181308 arm were analyzed for Survivin Index.
Data presented are the ratio of Day 2 survivin index to the baseline survivin index. Survivin is a protein expressed in tumor cells, including acute myeloid leukemia (AML), which regulates mitosis and prevents tumor cell death. Survivin index was calculated as (\[blast survivin mean equivalent fluorochrome (MEFL) - blast isotypic control MEFL\]/blast isotypic control MEFL).
Outcome measures
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Change From Baseline in Survivin Index at Day 2
|
0.43 ratio
Interval 0.28 to 0.67
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study treatment discontinuation up to 21 days post study treatment discontinuationPopulation: All participants who received at least one dose of study drug.
Deaths due to progressive disease (PD) and unknown cause are not considered adverse events. Deaths due to PD and unknown cause occurring during the 21-day follow-up period after treatment discontinuation are reported here and for those occurring while participants were on treatment are reported in the Participant Flow. Deaths due to serious adverse events occurred during the study including the 21-day follow-up period are reported in the Reported Adverse Events section.
Outcome measures
| Measure |
LY2181308
n=8 Participants
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 Participants
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up
Death due to progressive disease
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up
Death due to unknown cause
|
1 Participants
|
0 Participants
|
Adverse Events
LY2181308
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2181308 + Idarubicin + Cytarabine
Serious events: 13 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2181308
n=8 participants at risk
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 participants at risk
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
43.8%
7/16 • Number of events 7
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Clostridial infection
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Sepsis
|
50.0%
4/8 • Number of events 4
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Septic shock
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Mental status changes
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
Other adverse events
| Measure |
LY2181308
n=8 participants at risk
750 milligrams (mg) was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond. Cycle length: 28 days.
|
LY2181308 + Idarubicin + Cytarabine
n=16 participants at risk
LY2181308: 750 mg was administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 and beyond.
Idarubicin: 12 milligrams per square meter (mg/m²) was administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 and beyond.
Cytarabine: 1.5 grams per square meter (g/m²) was administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 and beyond.
Cycle length: 28 days.
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
50.0%
8/16 • Number of events 8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Cardiac disorders
Cardiac failure congestive
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
25.0%
4/16 • Number of events 5
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Eye disorders
Conjunctival hyperaemia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Eye disorders
Dry eye
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Eye disorders
Eye pain
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Eye disorders
Eye swelling
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
43.8%
7/16 • Number of events 7
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Abdominal rebound tenderness
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
4/8 • Number of events 4
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
31.2%
5/16 • Number of events 5
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Gingival swelling
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
43.8%
7/16 • Number of events 8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Odynophagia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Tongue discolouration
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Asthenia
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Catheter site erythema
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Catheter site pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Chest pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
37.5%
6/16 • Number of events 6
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Crepitations
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Facial pain
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
25.0%
4/16 • Number of events 5
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Infusion site pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Injection site pruritus
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Injection site reaction
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Oedema
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 6
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Pain
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Epiglottitis
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Escherichia bacteraemia
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Infusion site infection
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Glomerular filtration rate
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Weight decreased
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Investigations
Weight increased
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Fluid overload
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
25.0%
4/16 • Number of events 4
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Dizziness
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 4
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Somnolence
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Confusional state
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Depressed mood
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Insomnia
|
37.5%
3/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
31.2%
5/16 • Number of events 5
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Psychiatric disorders
Mental status changes
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Incontinence
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/5
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
16.7%
1/6 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
37.5%
6/16 • Number of events 7
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
12.5%
2/16 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
50.0%
8/16 • Number of events 8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
18.8%
3/16 • Number of events 4
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
25.0%
2/8 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
0.00%
0/16
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 2
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
25.0%
2/8 • Number of events 3
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
25.0%
4/16 • Number of events 5
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
25.0%
4/16 • Number of events 8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Vascular disorders
Haematoma
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
31.2%
5/16 • Number of events 6
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/8
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
6.2%
1/16 • Number of events 1
Deaths due to progressive disease and unknown cause are not considered adverse events and are reported in the Participant Flow for those participants who died while taking study drug. Deaths due to progressive disease or unknown cause during the 21-day post-study treatment follow-up period are reported in the Other Pre-Specified Outcome Measure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60