Trial Outcomes & Findings for A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer (NCT NCT02508389)
NCT ID: NCT02508389
Last Updated: 2021-09-20
Results Overview
Assessed from the first determination of ≥Grade 3 OM to the first instance of non-severe OM (≤Grade 2), without a subsequent instance of ≥Grade 3
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
223 participants
Primary outcome timeframe
From start of Intensity-modulated radiation therapy (IMRT) through 8 weeks follow-up, an average of 15 weeks
Results posted on
2021-09-20
Participant Flow
Participant milestones
| Measure |
Low Dose GC4419: 30mg/Day
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
76
|
74
|
|
Overall Study
COMPLETED
|
45
|
45
|
42
|
|
Overall Study
NOT COMPLETED
|
28
|
31
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
Baseline characteristics by cohort
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 9.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of Intensity-modulated radiation therapy (IMRT) through 8 weeks follow-up, an average of 15 weeksPopulation: intent to treat population
Assessed from the first determination of ≥Grade 3 OM to the first instance of non-severe OM (≤Grade 2), without a subsequent instance of ≥Grade 3
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Duration (in Days) of Radiation Induced Severe Oral Mucositis (OM) Per World Health Organization (WHO) Criteria
|
8 days
Interval 0.0 to 93.0
|
1.5 days
Interval 0.0 to 100.0
|
19 days
Interval 0.0 to 83.0
|
SECONDARY outcome
Timeframe: First dose of IMRT through the completion of IMRT, estimated to be up to 7 weeks.Population: Treated Population
Number of participants with treatment emergent adverse events (TEAE) per arm
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=72 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=72 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Number of Subjects with at least one TEAE
|
73 participants
|
72 participants
|
72 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Number of Subjects with at least one serious TEAE
|
34 participants
|
34 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Minimum of 60 Gy administered to tumor, approximately 30 IMRT fractions, which is estimated to be 6-7 weeks.Population: Intent to treat population
Number of participants who experience severe OM from the first IMRT fraction through the last IMRT fraction
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Number of Participants Who Experience Severe OM
|
29 participants
|
28 participants
|
43 participants
|
SECONDARY outcome
Timeframe: First dose of IMRT through the completion of IMRT, estimated to be up to 6-7 weeks.Population: Intent to treat population
Number of Participants who experienced Grade 4 OM
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Number of Participants Who Experienced Grade 4 OM From the First IMRT Fraction Through the Last IMRT Fraction
|
44 participants
|
33 participants
|
48 participants
|
SECONDARY outcome
Timeframe: Onset of Severe OM, estimated to be between first dose of IMRT and 7 weeks.Population: Intent to treat population
Onset of severe OM: number of IMRT fractions delivered at onset of severe OM
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Number of IMRT Fractions Delivered at Onset of Severe OM
|
33 IMRT Fractions
Interval 25.0 to 35.0
|
35 IMRT Fractions
Interval 28.0 to 35.0
|
28 IMRT Fractions
Interval 22.0 to 33.0
|
SECONDARY outcome
Timeframe: Onset of Grade 4 OM, estimated to be between first dose of IMRT and 7 weeks.Population: Intent to Treat Population
Number of Participants who experienced Grade 4 OM
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Number of Participants Who Experienced Grade 4 Oral Mucocitis (OM) From the First IMRT Fraction Through the Last IMRT Fraction
|
15 participants
|
12 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Up to 1 year following completion of chemoradiation.Population: Intent to treat population
Effect of treatment assignment on tumor outcomes (locoregional failure, distant metastases, progression-free survival, overall survival) Only 73 subjects in Placebo Arm were analyzed for locoregional failure, distant disease and progression-free survival because 1 subject was determined after enrollment to have a non-head and neck cancer and was therefore excluded from these analyses
Outcome measures
| Measure |
Low Dose GC4419: 30mg/Day
n=73 Participants
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=76 Participants
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=74 Participants
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Number of Participants With Tumor Outcomes Defined as Locoregional Failure, Distant Metastases, Disease Progression and Deaths
Number With Distant Disease
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Tumor Outcomes Defined as Locoregional Failure, Distant Metastases, Disease Progression and Deaths
Number With Locoregional Failure
|
7 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Tumor Outcomes Defined as Locoregional Failure, Distant Metastases, Disease Progression and Deaths
Number with Progressive Disease
|
15 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Tumor Outcomes Defined as Locoregional Failure, Distant Metastases, Disease Progression and Deaths
Number of Deaths
|
11 Participants
|
10 Participants
|
10 Participants
|
Adverse Events
Low Dose GC4419: 30mg/Day
Serious events: 34 serious events
Other events: 73 other events
Deaths: 1 deaths
High Dose GC4419: 90mg/Day
Serious events: 34 serious events
Other events: 72 other events
Deaths: 1 deaths
Placebo
Serious events: 28 serious events
Other events: 72 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Low Dose GC4419: 30mg/Day
n=73 participants at risk
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=72 participants at risk
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=72 participants at risk
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Lung Infection
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Sepsis
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Clostridium difficile infection
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Oral herpes
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Cystitis
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Device related infection
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Infection
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Odynophagia
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Dehydration
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Hyponatraemia
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Malnutrition
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Failure to thrive
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Hyperglycaemia
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Hypocalcaemia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Hypotension
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Deep vein thrombosis
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Hypertension
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Renal and urinary disorders
Acute kidney injury
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Pyrexia
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Asthenia
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Pain
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Cardiac disorders
Atrial flutter
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Guillain-Barre syndrome
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Seizure
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Investigations
Weight decreased
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
Other adverse events
| Measure |
Low Dose GC4419: 30mg/Day
n=73 participants at risk
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
High Dose GC4419: 90mg/Day
n=72 participants at risk
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
Placebo
n=72 participants at risk
Placebo daily, prior to IMRT
Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
13.9%
10/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Cytopenia
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Fatigue
|
60.3%
44/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
65.3%
47/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
69.4%
50/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Pyrexia
|
20.5%
15/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
18.1%
13/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
20.8%
15/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Chills
|
13.7%
10/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
13.9%
10/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Oedema peripheral
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Asthenia
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Face oedema
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
General disorders
Pain
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Dehydration
|
37.0%
27/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
41.7%
30/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
31.9%
23/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.1%
22/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
43.1%
31/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
31.9%
23/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
26.0%
19/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
29.2%
21/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
18.1%
13/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
21.9%
16/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
25.0%
18/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
22.2%
16/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.1%
11/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
13.9%
10/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
63.0%
46/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
61.1%
44/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
63.9%
46/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
23.3%
17/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
26.4%
19/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
23.6%
17/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
21.9%
16/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
22.2%
16/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
25.0%
18/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.8%
13/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
8/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
12.5%
9/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
12.3%
9/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Dysgeusia
|
54.8%
40/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
43.1%
31/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
48.6%
35/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Headache
|
21.9%
16/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
33.3%
24/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
23.6%
17/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Dizziness
|
21.9%
16/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
26.4%
19/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
12.5%
9/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Paraesthesia
|
9.6%
7/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
16.7%
12/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
12.5%
9/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Nervous system disorders
Syncope
|
5.5%
4/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Oral candidiasis
|
45.2%
33/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
43.1%
31/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
29.2%
21/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Candida infection
|
17.8%
13/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
16.7%
12/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Urinary tract infection
|
5.5%
4/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Mucosal infection
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
50.7%
37/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
52.8%
38/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
47.2%
34/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
11.0%
8/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Investigations
Weight decreased
|
39.7%
29/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
44.4%
32/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
34.7%
25/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Investigations
Electrocardiogram QT prolonged
|
8.2%
6/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
16.7%
12/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
7/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
12.5%
9/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.5%
4/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Hypotension
|
16.4%
12/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
23.6%
17/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Hypertension
|
9.6%
7/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
16.7%
12/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
13.9%
10/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Flushing
|
11.0%
8/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Orthostatic hypotension
|
5.5%
4/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Vascular disorders
Deep vein thrombosis
|
5.5%
4/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Ear and labyrinth disorders
Tinnitus
|
26.0%
19/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
20.8%
15/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
26.4%
19/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Ear and labyrinth disorders
Ear pain
|
6.8%
5/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.2%
6/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Psychiatric disorders
Insomnia
|
15.1%
11/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Psychiatric disorders
Anxiety
|
11.0%
8/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
8.2%
6/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Psychiatric disorders
Depression
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.6%
7/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
12.5%
9/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
4.2%
3/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Renal and urinary disorders
Acute kidney injury
|
13.7%
10/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Renal and urinary disorders
Renal disorder
|
5.5%
4/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Cardiac disorders
Sinus tachycardia
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Eye disorders
Vision blurred
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
9.7%
7/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
0.00%
0/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Nausea
|
68.5%
50/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
81.9%
59/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
75.0%
54/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Constipation
|
58.9%
43/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
63.9%
46/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
52.8%
38/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Vomiting
|
52.1%
38/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
48.6%
35/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
47.2%
34/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Dysphagia
|
42.5%
31/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
47.2%
34/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
43.1%
31/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Diarrhoea
|
42.5%
31/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
30.6%
22/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
38.9%
28/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.3%
9/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
16.7%
12/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
15.3%
11/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Dyspepsia
|
17.8%
13/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
11.1%
8/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
8.3%
6/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Odynophagia
|
8.2%
6/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
6.9%
5/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
2.8%
2/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Gastrointestinal disorders
Glossodynia
|
4.1%
3/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
5.6%
4/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
1.4%
1/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
91.8%
67/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
87.5%
63/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
88.9%
64/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Leukopenia
|
37.0%
27/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
38.9%
28/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
38.9%
28/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.7%
18/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
23.6%
17/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
26.4%
19/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
|
Blood and lymphatic system disorders
Anaemia
|
27.4%
20/73 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
23.6%
17/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
12.5%
9/72 • from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER