Trial Outcomes & Findings for Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas (NCT NCT01318642)
NCT ID: NCT01318642
Last Updated: 2024-11-08
Results Overview
The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From randomization to the date of either disease progression or death, up to 181 days progression or death
Results posted on
2024-11-08
Participant Flow
The Safety Population was used for all summaries (including serious and non-serious adverse events). Only 8/10 subjects received at least 1 dose of protocol-specified treatment and therefore were included in the Safety Population.
Participant milestones
| Measure |
Placebo + Gemcitabine
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Subjects with locally advanced unresectable adenocarcinoma of the pancreas
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the date of either disease progression or death, up to 181 days progression or deathThe time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
|
NA Months
lack of participants with events
|
NA Months
lack of participants with events
|
SECONDARY outcome
Timeframe: Up to 181 daysOS - time from study day 1 to death (by any cause)
Outcome measures
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Overall Survival
|
NA Months
lack of participants with events
|
NA Months
lack of participants with events
|
SECONDARY outcome
Timeframe: Up to 4 monthsMeasured via CTCAE v3.0
Outcome measures
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 181 daysPFS rates - subjects with disease progression (PD) or death at the timepoint; OS rates - subjects alive at the timepoint; ORR - tumor response assessment of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST); DCR - subjects with PR, CR, or SD Per RECIST: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease progression=at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study; stable disease is disease that is not partial or progressed
Outcome measures
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Progression Free Survival Rate at 3 months
|
2 Participants
|
0 Participants
|
|
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Progression Free Survival Rate at 6 months
|
2 Participants
|
0 Participants
|
|
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Overall Survival Rate at 3 months
|
5 Participants
|
3 Participants
|
|
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Overall Survival Rate at 6 months
|
4 Participants
|
3 Participants
|
|
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Objective Response Rate
|
NA Participants
lack of participants with events (e.g. PR, CR)
|
NA Participants
lack of participants with events (e.g. PR, CR)
|
|
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Disease Control Rate
|
NA Participants
lack of participants with events (e.g. PR, CR, SD)
|
NA Participants
lack of participants with events (e.g. PR, CR, SD)
|
SECONDARY outcome
Timeframe: Up to 181 daysDOR - time from the first observation of an objective response (subjects with CR or PR) to the time of PD or death; Per RECIST: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease progression=at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study; stable disease is disease that is not partial or progressed
Outcome measures
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Duration of Response
|
NA Months
lack of participants with events (eg CR or PR)
|
NA Months
lack of participants with events (eg CR or PR)
|
SECONDARY outcome
Timeframe: Up to 181 dayspost-dose anti-AMG 479 antibody positive rate
Outcome measures
| Measure |
Placebo + Gemcitabine
n=5 Participants
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 Participants
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Number of Participants With Anti-AMG 479 Antibodies
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo + Gemcitabine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
AMG 479 20 mg/kg + Gemcitabine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Gemcitabine
n=5 participants at risk
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 participants at risk
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
General disorders
General physical health deterioration
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Malaise
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
Other adverse events
| Measure |
Placebo + Gemcitabine
n=5 participants at risk
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
|
AMG 479 20 mg/kg + Gemcitabine
n=3 participants at risk
ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
100.0%
3/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Fatigue
|
60.0%
3/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
66.7%
2/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
2/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Pyrexia
|
40.0%
2/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
66.7%
2/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Investigations
C-reactive protein increased
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Chest discomfort
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Chills
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Psychiatric disorders
Confusional state
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Nervous system disorders
Febrile convulsion
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
General physical health deterioration
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Infections and infestations
Infection
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Malaise
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
General disorders
Mucosal inflammation
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
0.00%
0/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
33.3%
1/3 • For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place