Trial Outcomes & Findings for Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors (NCT NCT01609790)
NCT ID: NCT01609790
Last Updated: 2022-07-21
Results Overview
Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment \> 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is \>45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is \<= 15%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
From start of treatment to 4 weeks.
Results posted on
2022-07-21
Participant Flow
Participant milestones
| Measure |
Cohort 1: Safety Run-In
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+Placebo
Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
|
Cohort 2: Bevacizumab+AMG 386
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
65
|
65
|
|
Overall Study
COMPLETED
|
6
|
58
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
8
|
Reasons for withdrawal
| Measure |
Cohort 1: Safety Run-In
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+Placebo
Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
|
Cohort 2: Bevacizumab+AMG 386
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
7
|
8
|
Baseline Characteristics
Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: Safety Run-In
n=6 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+Placebo
n=58 Participants
Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
|
Cohort 2: Bevacizumab+AMG 386
n=57 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
58 years
n=7 Participants
|
57 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to 4 weeks.Population: All eligible patients who started study treatment
Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment \> 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is \>45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is \<= 15%.
Outcome measures
| Measure |
Safety Run-In
n=6 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1)
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: From randomization to six months.Population: Randomized patients evaluable for 6 months progression-free survival (PFS).
As determined by central review of MRI exams, assessed using RANO criteria for progression that is defined by any of the following: \> 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease.
Outcome measures
| Measure |
Safety Run-In
n=56 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
n=53 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Six-month Progression-free Survival (Cohort 2)
|
41.1 percentage of participants
Interval 28.2 to 54.0
|
22.6 percentage of participants
Interval 11.4 to 33.9
|
SECONDARY outcome
Timeframe: From start of treatment up to 3 years.Population: Randomized and eligible patients who started protocol treatment.
Adverse events (AEs) are graded by using CTCAE 4.0. Possibly/probably/definitely related to protocol treatment AEs are considered.
Outcome measures
| Measure |
Safety Run-In
n=57 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
n=57 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)
|
21 participants
|
20 participants
|
SECONDARY outcome
Timeframe: From randomization up to 3 years.Population: All randomized and eligible patients.
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.
Outcome measures
| Measure |
Safety Run-In
n=58 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
n=57 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Overall Survival (Cohort 2)
|
11.5 Months
Interval 8.4 to 14.2
|
7.5 Months
Interval 6.8 to 10.1
|
SECONDARY outcome
Timeframe: From randomization up to 3 years.Population: All randomized and eligible patients.
Progression-free survival time is measured from randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.
Outcome measures
| Measure |
Safety Run-In
n=58 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
n=57 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Progression-free Survival (Cohort 2)
|
4.8 percentage of participants
Interval 3.8 to 7.1
|
4.2 percentage of participants
Interval 3.7 to 5.6
|
SECONDARY outcome
Timeframe: From randomization up to 3 years.Population: All randomized and eligible patients.
Proportion of patients with best overall response of complete response (CR) or partial response (PR) recorded from the start of the treatment until disease progression/recurrence. Response determined by site-reported radiology review of MRI exams using Response Assessment in Neuro-Oncology Criteria (RANO) criteria. CR: Complete disappearance of all enhancing measurable disease (MD) + non-measurable disease (NMD) sustained \>= 4 wks; No new lesions; Stable or improved non-enhancing (T2/FLAIR) lesions; Off corticosteroids (or on physiologic replacement doses only); Stable/improved clinically. PR: \>= 50% decrease vs. baseline of sum of products of perpendicular diameters of all measurable enhancing lesions sustained \>= 4 wks; No progression of NMD; No new lesions; Stable/improved non-enhancing (T2/FLAIR) lesions on \<= dose of corticosteroids vs. baseline scan; Corticosteroid dose at evaluation scan \<= baseline scan dose; Stable or improved clinically. NMD only cannot be a CR or PR.
Outcome measures
| Measure |
Safety Run-In
n=58 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
n=57 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Radiographic Response Rate (Cohort 2)
|
5.9 percentage of participants
Interval 0.0 to 12.3
|
4.2 percentage of participants
Interval 0.0 to 9.8
|
SECONDARY outcome
Timeframe: From randomization up to 3 years.Population: Eligible patients
Feasibility of trebananib weekly in combination with bevacizumab every 2 weeks, measured by the percentage of patients requiring dose reduction/interruption or discontinuation in the first 2 and subsequent courses (Cohort 1)
Outcome measures
| Measure |
Safety Run-In
n=6 Participants
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+AMG 386
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|
|
Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)
In first 2 cycles
|
6 Participants
|
—
|
|
Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)
In first 6 cycles
|
3 Participants
|
—
|
|
Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)
In first 12 cycles
|
5 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens.Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Safety Run-In
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Bevacizumab+Placebo
Serious events: 22 serious events
Other events: 57 other events
Deaths: 0 deaths
Cohort 2: Bevacizumab+AMG 386
Serious events: 20 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Safety Run-In
n=6 participants at risk
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+Placebo
n=57 participants at risk
Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
|
Cohort 2: Bevacizumab+AMG 386
n=57 participants at risk
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|---|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Flu like symptoms
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Gait disturbance
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Seizure
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Stroke
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Cohort 1: Safety Run-In
n=6 participants at risk
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
Cohort 2: Bevacizumab+Placebo
n=57 participants at risk
Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
|
Cohort 2: Bevacizumab+AMG 386
n=57 participants at risk
Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.6%
14/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Endocrine disorders
Cushingoid
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Dry eye
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.3%
15/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.8%
13/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Fecal incontinence
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.6%
14/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chills
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema face
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
66.7%
4/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
38/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
64.9%
37/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fever
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Gait disturbance
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.8%
13/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Injection site reaction
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Localized edema
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Malaise
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Esophageal infection
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Soft tissue infection
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Vaginal infection
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fracture
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.3%
15/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
CPK increased
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Investigations - Other
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.8%
17/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.3%
15/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight gain
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight loss
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
White blood cell decreased
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
38.6%
22/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.1%
16/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Concentration impairment
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysphasia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Facial muscle weakness
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Facial nerve disorder
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
56.1%
32/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
19/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Nervous system disorders - Other
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Seizure
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusion
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hematoma
|
33.3%
2/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension
|
50.0%
3/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.1%
24/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
43.9%
25/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Randomized and eligible patients who started protocol treatment are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60